Regulatory Affairs Specialist II

at  Thermo Fisher Scientific

JOB DESCRIPTION

When you are part of Thermo Fisher Scientific, you will do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best.
Working as part of our Microbiology Division (MBD), within the Specialty Diagnostics Group, you’ll play an active part in helping us to achieve our mission to enable our customers to make the world healthier, cleaner and safer. The Microbiology Division discovers microbiological solutions for the diagnosis of infectious disease and detection of bacterial contamination. We serve public health, clinical laboratories, food companies, environmental screening and pharmaceutical laboratories with a portfolio of products that include culture media, antimicrobial susceptibility testing solutions and market-leading molecular solutions for food safety testing.

POSITION SUMMARY

This is a regulatory position within Thermo Fisher Scientific, Microbiology Division (MBD), working in the Product Regulatory Affairs (RA) team as a Product RA Specialist to support MBD’s portfolio of clinical microbiology products.
As a Product RA specialist, you will assist in the management of product changes, the notification of such changes to global regulatory agencies, and the regulatory aspects throughout the entire product life cycle from development to discontinuation.
This role is in a team of Regulatory experts. This means you can always count on support and in-house expertise to support your actions and decisions. You can make a difference in this role and will have an impact on our team, and our products in this global role. In addition to this we have a very diverse and inclusive culture and there is enough room for personal growth.

EXPERIENCE, SKILLS AND ABILITIES REQUIRED

• Has a Microbiology (or another biological or life science related) degree or experience in microbiology laboratory setting. Experience in a regulated environment or working in a Quality or Operations role would also be considered.
• Excellent oral and written communication skills.
• Ability to work both independently and as a team member, also of a cross-functional team.
• Strong attention to detail with problem analysis and decision-making skills.
• Self-starter who can take concepts and direction and produce desirable results.
• Ability to prioritize multiple tasks functions in a global, multi-site organization.
• Good understanding of various computer software, such as SAP and MasterControl as well as Microsoft Word, Excel and PowerPoint.
• Consistently demonstrates our 4i Values of Integrity, Intensity, Innovation & Involvement
• Puts the Customer First
• Thinks and acts with the customer always in mind and is dedicated to meeting or exceeding customer expectations
• Can explain who their customers are, and how their daily work impacts the (internal and/or external) customer
• Owns Their Results
• Takes personal accountability for their daily presence, performance, and productivity and always exercises good judgement
• Is highly reliable and consistently meets or exceeds job requirements
• Takes personal accountability for adherence to safety, compliance, quality, and security
• Finds a Better Way Every Day
• Adopt continuous improvement, asks questions and seeks opportunities to learn from others and from new experiences
• Takes the initiative to share ideas on how to make jobs easier and strengthen our performance
  At Thermo Fisher Scientific, each one of our 100000+ extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

• Review and maintain technical files, regulatory submissions, responses to Notified Body questions, and labelling for completeness and quality.
• Timely review of change requests from operations, identification of significant changes and impact on existing market access licenses. Supporting the Operation, Sourcing and Purchasing teams for the successful completion of engineering change activities.
• Processing of customer services and commercial enquiries in relation to products classifications and regulatory status.
• Work collaboratively with Market Access team, local RA and commercial partners to gain and maintain pre-market licenses globally for the product groups.
• Liaise with the Technical Writing team to ensure that the impact of changes on technical documentation is considered, and that accurate and timely responses are given to questions posed as part of the Notified Body file review.
• Support the Quality Assurance team during notified body, customer and authority audits. Ensuring we are audit ready.